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Pramlintide Improved Glycemic Control and Reduced Weight in Patients With Type 2 Diabetes Using Basal Insulin

¹ Oregon Health & Science University, Portland, OR
² Amylin Pharmaceuticals, Inc., San Diego, CA

orville.kolterman{at}amylin.com

ABSTRACT

Objective: Assessment of efficacy and safety of pramlintide in patients with type 2 diabetes suboptimally controlled with basal insulin.

Research Design and Methods: In a 16-week, double-blind, placebo-controlled study, 212 patients using insulin glargine with/without oral antidiabetic agents (OAs) were randomized to addition of pramlintide (60 or 120 µg BID/TID) or placebo. Insulin glargine was adjusted targeting a fasting plasma glucose concentration 70-100 mg/dl. One co-primary endpoint was the change in A1C at Week 16. The other co-primary endpoint was a composite measure of overall diabetes control comprising A1C 7.0% or reduction 0.5%, mean daily postprandial glucose (PPG) increments 40 mg/dl, no increase in body weight, and no severe hypoglycemia. Patients meeting all four conditions at Week 16 achieved this endpoint.

Results: More pramlintide- than placebo-treated patients achieved the composite endpoint (25% vs. 7%, P <0.001). Reductions (mean ± SE) in A1C (–0.70 ± 0.11% vs. –0.36 ± 0.08%, P <0.05) and PPG increments (–24.4 ± 3.6 mg/dl vs. –0.4 ± 3.0 mg/dl, P <0.0001) were greater in pramlintide- vs. placebo-treated patients, respectively. Glycemic improvements were accompanied by progressive weight loss with pramlintide and weight gain with placebo (–1.6 ± 0.3 kg vs. +0.7 ± 0.3 kg, P <0.0001). No treatment-related severe hypoglycemia occurred.

Conclusions: Pramlintide improved multiple glycemic parameters and reduced weight with no increase in hypoglycemia in patients with type 2 diabetes not achieving glycemic targets with basal insulin ± OAs.

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